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Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis (ISAR-DESIRE-3)

Primary Purpose

Heart Disease, Ischemia, Restenosis

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Taxus stent

SeQuent Please

Conventional Balloon Catheter

About this trial

This is an interventional treatment trial for Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels.
Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria:

Age < 18 years.
Cardiogenic shock.
Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
Target lesion located in the left main trunk or bypass graft.
Target lesion located in small vessel (vessel size < 2.0 mm).
Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min).
Contraindications to antiplatelet therapy, paclitaxel, stainless steel, cobalt, chrome.
Pregnancy (present, suspected or planned) or positive pregnancy test.
Previous enrollment in this trial.
Patient's inability to fully comply with the study protocol.

Sites / Locations

1. Med. Klinik, Klinikum rechts der Isar
Herz-Zentrum
Deutsches Herzzentrum

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Paclitaxel-eluting stent

Plain Balloon

Paclitaxel-eluting balloon

Arm Description

Paclitaxel-eluting stent (Taxus)

plain balloon angioplasty

SeQuent Please

Outcomes

Primary Outcome Measures

Percent in-segment diameter stenosis at follow-up angiography

Secondary Outcome Measures

In-segment minimal luminal diameter

In-segment binary angiographic restenosis

Combined incidence of death or myocardial infarction

Incidence of thrombosis

Full Information

NCT ID

NCT00987324

First Posted

August 27, 2009

Last Updated

November 18, 2016

Sponsor

Deutsches Herzzentrum Muenchen

1. Study Identification

Unique Protocol Identification Number

NCT00987324

Brief Title

Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis

Acronym

ISAR-DESIRE-3

Official Title

Randomized Trial of Paclitaxel-Eluting Balloon, Paclitaxel-Eluting Stent and Plain Balloon Angioplasty for Restenosis in "-Limus"-Eluting Coronary Stents

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective in the treatment of restenosis after implantation of "Limus"-eluting stents, (LES).

Detailed Description

The use of drug-eluting stents (DES) has led to a drastic reduction of restenosis rates compared to bare metal stents (BMS), but 5% to 10% of patients receiving DES are still in need of revascularization of the treated vessel. Two important families of drugs are used for stent coating: paclitaxel belonging to the taxane family, and the "limus"-family such as sirolimus, everolimus, zotarolimus, biolimus A9 and pimecrolimus. Data regarding the optimal treatment of in-DES-restenosis is very limited. Implanting a new DES for in-DES-restenosis has been reported to be associated with re-restenosis rates as high as 43%. Several recent well published studies have shown a substantial reduction of restenosis using paclitaxel-eluting balloons (PEB) for de-novo lesions and BMS-restenotic lesions. The objective of this randomized trial is to assess the hypothesis, that PEB are non-inferior to paclitaxel-eluting-stents (PES) for restenosis in "limus"-eluting-stents (LES), and both, PEB and PES, are superior to plain angioplasty in patients with restenosis after initial LES implantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Disease, Ischemia, Restenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

402 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paclitaxel-eluting stent

Arm Type

Experimental

Arm Description

Paclitaxel-eluting stent (Taxus)

Arm Title

Plain Balloon

Arm Type

Active Comparator

Arm Description

plain balloon angioplasty

Arm Title

Paclitaxel-eluting balloon

Arm Type

Experimental

Arm Description

SeQuent Please

Intervention Type

Device

Intervention Name(s)

Taxus stent

Intervention Description

Implantation of paclitaxel-eluting stent

Intervention Type

Device

Intervention Name(s)

SeQuent Please

Intervention Description

Dilation with SeQuent Please (paclitaxel-eluting balloon)

Intervention Type

Device

Intervention Name(s)

Conventional Balloon Catheter

Intervention Description

Ryuijin, Trek

Primary Outcome Measure Information:

Title

Percent in-segment diameter stenosis at follow-up angiography

Time Frame

6-8 months

Secondary Outcome Measure Information:

Title

In-segment minimal luminal diameter

Time Frame

6-8 months

Title

In-segment binary angiographic restenosis

Time Frame

6-8 months

Title

Combined incidence of death or myocardial infarction

Time Frame

1 and 2 years

Title

Incidence of thrombosis

Time Frame

1 and 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study. In women with childbearing potential a negative pregnancy test is mandatory. Exclusion Criteria: Age < 18 years. Cardiogenic shock. Acute ST-elevation myocardial infarction within 48 hours from symptom onset. Target lesion located in the left main trunk or bypass graft. Target lesion located in small vessel (vessel size < 2.0 mm). Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance. Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min). Contraindications to antiplatelet therapy, paclitaxel, stainless steel, cobalt, chrome. Pregnancy (present, suspected or planned) or positive pregnancy test. Previous enrollment in this trial. Patient's inability to fully comply with the study protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julinda Mehilli, MD

Organizational Affiliation

Deutsches Herzzentrum Munich

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Adnan Kastrati, MD

Organizational Affiliation

Deutsches Herzzentrum

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Klaus Tiroch, MD

Organizational Affiliation

Deutsches Herzzentrum

Official's Role

Study Director

Facility Information:

Facility Name

1. Med. Klinik, Klinikum rechts der Isar

City

Munich

State/Province

Bavaria

ZIP/Postal Code

81675

Country

Germany

Facility Name

Herz-Zentrum

City

Bad Krozingen

ZIP/Postal Code

79189

Country

Germany

Facility Name

Deutsches Herzzentrum

City

Munich

ZIP/Postal Code

80636

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

19487593

Citation

Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1.

Results Reference

background

PubMed Identifier

26003022

Citation

Kufner S, Cassese S, Valeskini M, Neumann FJ, Schulz-Schupke S, Hoppmann P, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A, Byrne RA; ISAR-DESIRE 3 Investigators. Long-Term Efficacy and Safety of Paclitaxel-Eluting Balloon for the Treatment of Drug-Eluting Stent Restenosis: 3-Year Results of a Randomized Controlled Trial. JACC Cardiovasc Interv. 2015 Jun;8(7):877-84. doi: 10.1016/j.jcin.2015.01.031. Epub 2015 May 20.

Results Reference

derived

PubMed Identifier

23206837

Citation

Byrne RA, Neumann FJ, Mehilli J, Pinieck S, Wolff B, Tiroch K, Schulz S, Fusaro M, Ott I, Ibrahim T, Hausleiter J, Valina C, Pache J, Laugwitz KL, Massberg S, Kastrati A; ISAR-DESIRE 3 investigators. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial. Lancet. 2013 Feb 9;381(9865):461-7. doi: 10.1016/S0140-6736(12)61964-3. Epub 2012 Dec 1.

Results Reference

derived

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Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis

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